Validation of UK Protocols to Exclude Brain Blood Flow Du... | NCT05775263

Studies
Validation of UK Protocols to Exclude Brain Blood Flow During Normothermic Regional Perfusion (NRP)

NCT05775263

Sponsor

Papworth Hospital NHS Foundation Trust

Status

Unknown status

Last Update Posted

Nov 28, 2023Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Cerebral Blood Flow

Interventions

CT angiogram

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Estimated

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Jun 1, 2025Estimated

First Submitted Date

Mar 7, 2023

First Submission Date that Met QC Criteria

Mar 7, 2023

First Posted Date

Mar 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2023

Last Update Posted Date

Nov 28, 2023Actual

Name	Class
Cambridge University Hospitals NHS Foundation Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to evaluate both Abdominal Normothermic Regional Perfusion (A-NRP) and Thoracoabdominal-NRP (TA-NRP) techniques, proving that brain blood flow is not resumed during NRP. This will be assessed through the use of two modalities: CT angiogram of the brain and continuous Hb02 readings. The study group hypothesise that such assessment methods will provide evidence to indicate that brain blood flow is not present during NRP and promote trust in the use of such novel techniques in routine practice.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A-NRP			Procedure: CT angiogram
TA-NRP			Procedure: CT angiogram

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT angiogram	Procedure	CT angiography of the brain 30 minutes from establishment of NRP	A-NRP TA-NRP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CT angiogram	Brain blood flow	30 minutes from establishment of NRP

Secondary Outcomes

Measure	Description	Time Frame
Cerebral oximetry	HbO2 measurements (O2Hbi (Delta oxygenated), HHbi (Delta deoxygenated), and cHbi (Delta total))	Prior to withdrawal of life sustaining treatment to 30 minutes after establishment of NRP

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

DCD donors in Cambridge University Hospital
Planned A-NRP
Consent for study has been obtained
Those who meet the appropriate criteria for DCD donation following WOLST
≥ 18 years of age
≤ 75 years of age

Exclusion Criteria:

DBD organ donors
DCD organ donations outside of Cambridge University Hospital
DCD donors without planned A-NRP
DCD donors whose family have withheld consent for brain blood flow investigations.
Patients who do not meet the appropriate criteria for DCD donation following WOLST
Patients with injuries that will physically prevent use of the necessary assessment methods

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Donation after Circulatory Death (DCD) organ donors

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antonio Rubino	Contact	01223 639574		a.rubino@nhs.net
Thomas Howlett	Contact			thomas.howlett@nhs.net

Overall Officials

Not provided

Locations

Not provided